Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

April 21, 2016 updated by: Sun Pharma Advanced Research Company Limited
Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects willing to provide informed consent
  • Male or female subjects aged 18 to 65 years inclusive
  • Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
  • Non-smokers or ex-smokers

Exclusion Criteria:

  • Subjects with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg
  • Subjects who have a significant infection or known inflammatory process on screening or admission.
  • Subjects who are unlikely to co-operate with the requirements of the study.
  • Positive serology for infectious disease (hepatitisB or C , HIV) at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPARC1316 Dose 1
Subjects will be administered with SPARC1316 dose 1
Drug: SPARC1316 Dose 1
The subjects will receive SPARC1316.
Placebo Comparator: Placebo
The subjects will receive placebo.
Drug: Placebo
Other Names:
  • The subjects will receive a matching placebo by oral inhalation.
Experimental: SPARC1316 Dose 2
Subjects will be administered with SPARC1316 dose 2
Drug: SPARC1316 Dose 2
Experimental: SPARC1316 Dose 3
Subjects will be administered with SPARC1316 dose 3
Drug: SPARC1316 Dose 3
Experimental: SPARC1316 Dose 4
Subjects will be administered with SPARC1316 dose 4
Drug: SPARC1316 Dose 4
Experimental: SPARC1316 Dose 5
Subjects will be administered with SPARC1316 dose 5
Drug: SPARC1316 Dose 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Adverse Events
Time Frame: Two (2) Weeks
The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients
Two (2) Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPARC_Ltd_ CLR_13_16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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